| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 20885380190923 | TRUBREZ | TRUBREZ | Quilted TRUBREZ Premium Underpad, Maximum | KME | BEDDING, DISPOSABLE, MEDICAL | (Design) Cardinal Wings | |
| 2 | 20885380174305 | 8899EC | 8899EC | Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
| 3 | 20885380174299 | 8898EC | 8898EC | Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
| 4 | 20885380174282 | 8897EC | 8897EC | Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
| 5 | 20885380174275 | 8896EC | 8896EC | Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
| 6 | 20885380166348 | 88FS06XXL | 88FS06XXL | Nitrile Exam Gloves Flexal Comfort | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 7 | 20885380166331 | 88FS05XL | 88FS05XL | Nitrile Exam Gloves Flexal Comfort | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 8 | 20885380166324 | 88FS04L | 88FS04L | Nitrile Exam Gloves Flexal Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
| 9 | 20885380166317 | 88FS03M | 88FS03M | Nitrile Exam Gloves Flexal Comfort | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 10 | 20885380166300 | 88FS02S | 88FS02S | Nitrile Exam Gloves Flexal Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
| 11 | 20885380166294 | 88FS01XS | 88FS01XS | Nitrile Exam Gloves Flexal Comfort | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 12 | 20885380163965 | 88ES06XXL | 88ES06XXL | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
| 13 | 20885380163958 | 88ES05XL | 88ES05XL | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
| 14 | 20885380163941 | 88ES04L | 88ES04L | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
| 15 | 20885380163934 | 88ES03M | 88ES03M | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
| 16 | 20885380163927 | 88ES02S | 88ES02S | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
| 17 | 20885380163910 | 88ES01XS | 88ES01XS | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
| 18 | 20885380161268 | 88RTF06XXL | 88RTF06XXL | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 19 | 20885380161251 | 88RTF05XL | 88RTF05XL | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 20 | 20885380161244 | 88RTF04L | 88RTF04L | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 21 | 20885380161237 | 88RTF03M | 88RTF03M | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 22 | 20885380161220 | 88RTF02S | 88RTF02S | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 23 | 20885380161213 | 88RTF01XS | 88RTF01XS | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 24 | 20885380157384 | 88RT06XXL | 88RT06XXL | NITRILE EXAM GLOVES FLEXAL TOUCH | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
| 25 | 20885380157377 | 88RT05XL | 88RT05XL | NITRILE EXAM GLOVES FLEXAL TOUCH | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 26 | 20885380157360 | 88RT04L | 88RT04L | NITRILE EXAM GLOVES FLEXAL TOUCH | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 27 | 20885380157353 | 88RT03M | 88RT03M | NITRILE EXAM GLOVES FLEXAL TOUCH | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
| 28 | 20885380157346 | 88RT02S | 88RT02S | NITRILE EXAM GLOVES FLEXAL TOUCH | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
| 29 | 20885380157339 | 88RT01XS | 88RT01XS | NITRILE EXAM GLOVES FLEXAL TOUCH | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
| 30 | 20885380137157 | 88TN05XL | 88TN05XL | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
| 31 | 20885380140959 | 88TNF06XXL | 88TNF06XXL | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
| 32 | 20885380140942 | 88TNF05XL | 88TNF05XL | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
| 33 | 20885380140935 | 88TNF04L | 88TNF04L | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
| 34 | 20885380140881 | 88TNF03M | 88TNF03M | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
| 35 | 20885380140850 | 88TNF02S | 88TNF02S | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
| 36 | 20885380140843 | 88TNF01XS | 88TNF01XS | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
| 37 | 20885380137164 | 8815NB | 8815NB | Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
| 38 | 20885380137133 | 88TN04L | 88TN04L | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
| 39 | 20885380137126 | 88TN03M | 88TN03M | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
| 40 | 20885380137119 | 88TN02S | 88TN02S | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
| 41 | 20885380137102 | 88TN01XS | 88TN01XS | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
| 42 | 20885380137096 | 88TN06XXL | 88TN06XXL | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
| 43 | 20885380135528 | 8884DOTP | 8884DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
| 44 | 20885380135511 | 8883DOTP | 8883DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
| 45 | 20885380135504 | 8882DOTP | 8882DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
| 46 | 20885380135498 | 8881DOTP | 8881DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
| 47 | 20885380135481 | 8880DOTP | 8880DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
| 48 | 20885380135436 | S88RX05 | S88RX05 | Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restor Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moisturizes | LYZ | Vinyl patient examination glove | ESTEEM | |
| 49 | 20885380135429 | S88RX04 | S88RX04 | Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restor Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moisturizes | LYZ | Vinyl patient examination glove | ESTEEM | |
| 50 | 20885380135412 | S88RX03 | S88RX03 | Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restor Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moisturizes | LYZ | Vinyl patient examination glove | ESTEEM |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00657498000014 | 6300-020 | 6300-020 | For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma. | RELY® H.Pylori | STANBIO LABORATORY, L.P. |
| 2 | 00630414989907 | 10469596 | LHPGCM | H.Pylori - IMMULITE - CTL | IMMULITE® Systems HPG CONTROL H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 3 | 00630414964164 | 10381272 | LKHPG1 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 4 | 00630414961644 | 10381335 | L2KHPG6 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 5 | 00630414961637 | 10381336 | L2KHPG2 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 6 | 00630414960944 | 10385353 | L1KIDW1 | Infectious Disease Diluent - IMMULITE - CAL | IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 7 | 00613647000519 | 4581465021 | 23900535 | SURE-VUE H. PYLORI 30/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 8 | 00612479202719 | 5007 | TEST KIT, H PYLORI (10/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 9 | 00612479202702 | 5008 | TEST KIT, H PYLORI (25/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 10 | 00350770927459 | 92745 | 60480 | AVANOS* CLOTEST* Rapid Urease Test | AVANOS | AVANOS MEDICAL, INC. |
| 11 | 00350770926636 | 92663 | 60407 | HALYARD* CLOTEST* Jack Bean Urease Control Tablets | AVANOS | AVANOS MEDICAL, INC. |
| 12 | 00083059070040 | 7004 | The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antib The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori. | GAP®-IgG (Gastritis and Peptic Ulcer Test) | BIOMERICA, INC. | |
| 13 | B350GSD0110010 | GSD01-1001 | Gold Standard Diagnostics H. pylori ELISA IgA Test Kit | Gold Standard Diagnostics H. pylori ELISA IgA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
| 14 | B350GSD0110000 | GSD01-1000 | Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit | Gold Standard Diagnostics H. pylori ELISA IgG Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
| 15 | 50192253013717 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 16 | 50192253012239 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 17 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | QuickVue | QUIDEL CORPORATION |
| 18 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | QuickVue | QUIDEL CORPORATION |
| 19 | 20885380183642 | CH25 | CH25 | CH25 Cardinal Health H. pylori Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 20 | 20885380163583 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 21 | 20885380163576 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 22 | 20885380020282 | B1077-25 | B1077-25 | H.pylori Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 23 | 15099590625924 | 395160 | 395160 | ICON HP (30 Tests) | Icon | BECKMAN COULTER, INC. |
| 24 | 10815845020079 | 01P53-25 | Signify® | ALERE SAN DIEGO, INC. | ||
| 25 | 10815845020048 | 92405 | Clearview® | ALERE SAN DIEGO, INC. | ||
| 26 | 10796918001846 | 05-9494 | INSTANT-VIEW H. Pylori Whole Blood/Serum Cassette Test | INSTANT-VIEW H. Pylori Whole Blood/Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 27 | 10796918001839 | 05-9475 | INSTANT-VIEW H. pylori Rapid Test | INSTANT-VIEW H. pylori Rapid Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 28 | 10796918001822 | 05-9473 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 29 | 10796918001815 | 05-9472 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 30 | 10763924392206 | ID392 | ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived* | ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived* | JANT PHARMACAL CORPORATION | |
| 31 | 10743816001591 | BSP-406WB-25-02 | Status™ H. pylori card; 25 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
| 32 | 10743816001584 | BSP-406WB-10-02 | Status™ H. pylori card; 10 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
| 33 | 10743816001164 | BSP-406WB-30-07 | BSP-406WB-30-07 | Status™ H. pylori card; 30 Test kit- CE (Procedure Card) | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
| 34 | 10743816001157 | BSP-406WB-30-05 | BSP-406WB-30-05 | BioSign® H. pylori card; 30 Test kit (Procedure Card) | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
| 35 | 10743816001140 | BSP-406WB-10-01 | BSP-406WB-10-01 | BioSign® H. pylori card; 10 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
| 36 | 10743816001133 | BSP-406WB-35-01 | BSP-406WB-35-01 | BioSign® H. pylori card; 35 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
| 37 | 10722355002023 | IHP-30 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
| 38 | 10722355002016 | IHP-10 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
| 39 | 10304040155742 | 5702778 | 5702778 | Henry Schein One Step + H. Pylori | Henry Schein | HENRY SCHEIN, INC. |
| 40 | 10304040024154 | 9004071 | 9004071 | One Step + H Pylori Test | Henry Schein | HENRY SCHEIN, INC. |
| 41 | M220P0800953 | P080095 | P080095 | PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
| 42 | M1745140S1 | 05140S | 05140S | The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. | Serim® PyloriTek® Test Kit | SERIM RESEARCH CORPORATION |
| 43 | M1745140K1 | 05140K | 05140K | The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. | Serim® PyloriTek® Test Kit | SERIM RESEARCH CORPORATION |
| 44 | 08426950593805 | 708720 | 1. 1x H. pylori IgA ELISA microwell plate, (12-1 x 8 wells), with holder2. 1x 1. 1. 1x H. pylori IgA ELISA microwell plate, (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgA ELISA Low Positive4. 1x 1.2mL prediluted H. pylori IgA ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® H.pylori IgA ELISA | INOVA DIAGNOSTICS, INC. | |
| 45 | 08426950593256 | 708715 | 1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2 1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgG ELISA Low Positive4. 1x 1.2mL prediluted H. pylori IgG ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® H.pylori IgG ELISA | INOVA DIAGNOSTICS, INC. | |
| 46 | 08305900070040 | 7004 | The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antib The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori. | GAP®-IgG (Gastritis and Peptic Ulcer Test) | BIOMERICA, INC. | |
| 47 | 05391516748834 | 1206651 | 1206651 | Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
| 48 | 05391516748827 | 1206650 | 1206650 | Uni-Gold™ H. pylori Antigen, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
| 49 | 05391516747738 | 41-9002 | 41-9002 | Marsorb G, 10.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
| 50 | 05391516747721 | 40-1013 | 40-1013 | 10x Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |